id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2009-N-0592-0091,FDA,FDA-2009-N-0592,"OMB Review, Executive Order 12866 (E.O.)[Informed Consent Elements, January 4, 2011 (76 FR 256) ] - Reference",Other,REF-Reference,2011-02-17T05:00:00Z,2011,2,2011-02-17T05:00:00Z,,2013-08-11T04:44:17Z,,0,0,0900006480bf16bc
FDA-2009-N-0592-0076,FDA,FDA-2009-N-0592,"Reference 9a - ""Mayo Clinic Informed Consent, IRB Consent Form..."" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:17Z,,0,0,0900006480bc2082
FDA-2009-N-0592-0084,FDA,FDA-2009-N-0592,"Reference 9i - ""American College of Radiology Imaging Network (ACRIN), Protocol Development & Regulatory Resources, Sample Consent Research Study"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:13Z,,0,0,0900006480bc3de2
FDA-2009-N-0592-0079,FDA,FDA-2009-N-0592,"Reference 9d - ""University of Michigan Consent To Be Part of a Research Study"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:15Z,,0,0,0900006480bc208f
FDA-2009-N-0592-0081,FDA,FDA-2009-N-0592,"Reference 9f - ""Children's Hospital Boston, Research Consent Form"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:15Z,,0,0,0900006480bc2095
FDA-2009-N-0592-0077,FDA,FDA-2009-N-0592,"Reference 9b - ""Stanford University Research Consent Form"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:17Z,,0,0,0900006480bc2083
FDA-2009-N-0592-0078,FDA,FDA-2009-N-0592,"Reference 9c - ""Duke University Health System Consent to Participate in a Research Study"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:10Z,,0,0,0900006480bc208e
FDA-2009-N-0592-0087,FDA,FDA-2009-N-0592,"Reference 13 - ""FDA: A Guide to Informed Consent--Information Sheet"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:17Z,,0,0,0900006480bc3e0d
FDA-2009-N-0592-0074,FDA,FDA-2009-N-0592,"Reference 4 - ""Trials of War Criminals, Nuernberg Military Tribunals, Nuernberg Code"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:13Z,,0,0,0900006480bc207b
FDA-2009-N-0592-0085,FDA,FDA-2009-N-0592,"Reference 9j - ""National Cancer Institute Templates, Informed Consent Template for Cancer Treatment Trials, August 2009"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:16Z,,0,0,0900006480bc3de5
FDA-2009-N-0592-0071,FDA,FDA-2009-N-0592,"Reference 1 - ""Protection of Human Subjects;Informed Consent, Federal Register Volume 46 Number 17, Tuesday. January 27, 1981"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:12Z,,0,0,0900006480bc1ee7
FDA-2009-N-0592-0072,FDA,FDA-2009-N-0592,"Reference 2 - ""The Belmont Report..., April 18, 1979"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:12Z,,0,0,0900006480bc1ee9
FDA-2009-N-0592-0080,FDA,FDA-2009-N-0592,"Reference 9e - ""Informed Consent to Participate in Research, University of Texas at Austin"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:16Z,,0,0,0900006480bc2094
FDA-2009-N-0592-0089,FDA,FDA-2009-N-0592,"Reference 15 - ""Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable, April 25, 2006"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:11Z,,0,0,0900006480bc3e0f
FDA-2009-N-0592-0090,FDA,FDA-2009-N-0592,"Reference 16 - ""NIH: ClinicalTrials.gov “Basic Results Data Element Definitions (DRAFT), February 2010"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:14Z,,0,0,0900006480bc3e10
FDA-2009-N-0592-0075,FDA,FDA-2009-N-0592,"Reference 6 - ""World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:14Z,,0,0,0900006480bc207f
FDA-2009-N-0592-0070,FDA,FDA-2009-N-0592,"Reference List, (References 1-16) - [Informed Consent Elements; Final Rule] re FDA-2009-N-0592-0069",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:11Z,,0,0,0900006480bc480b
FDA-2009-N-0592-0073,FDA,FDA-2009-N-0592,"Reference 3 - ""National Research Act PL93-348"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:15Z,,0,0,0900006480bc207a
FDA-2009-N-0592-0086,FDA,FDA-2009-N-0592,"Reference 12 - ""FDA, Office of Planning, Risk Communication Staff, Analysis Note, July 30, 2010, Informal Testing of Clinical Trials Informed Consent Statement"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:12Z,,0,0,0900006480bc3e0c
FDA-2009-N-0592-0088,FDA,FDA-2009-N-0592,"Reference 14 - ""NIH-PRS Information: U.S. Public Law 110-85"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:11Z,,0,0,0900006480bc3e0e
FDA-2009-N-0592-0083,FDA,FDA-2009-N-0592,"Reference 9h - ""Walter Reed Army Medical Center, NCA Templates ""Informed Consent Form"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:13Z,,0,0,0900006480bc2f0e
FDA-2009-N-0592-0069,FDA,FDA-2009-N-0592,Informed Consent Elements,Rule,NFR-Notice of Final Rule,2011-01-04T05:00:00Z,2011,1,2011-01-04T05:00:00Z,,2011-06-11T16:28:13Z,2010-33193,0,0,0900006480bc4ae4
FDA-2009-N-0592-0082,FDA,FDA-2009-N-0592,"Reference 9g - ""Partners HealthCare System Research Consent Form, February 2010"" - [Informed Consent Elements; Final Rule]",Supporting & Related Material,BKG-Background Material,2011-01-04T05:00:00Z,2011,1,,,2011-06-11T16:28:16Z,,0,0,0900006480bc2096
FDA-2009-N-0592-0004,FDA,FDA-2009-N-0592,"Reference 3 - ‘‘National Research Act, Title II (Public Law 93–348, July 12, 1974)""  - [Informed Consent Elements]",Supporting & Related Material,BKG-Background Material,2009-12-30T05:00:00Z,2009,12,,,2010-03-04T04:00:30Z,,0,0,0900006480a733d4
FDA-2009-N-0592-0002,FDA,FDA-2009-N-0592,"Reference 1 - ‘‘Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10,  Vol. 2, pp. 181–182. Office, 1949"" - [Informed Consent Elements]",Supporting & Related Material,BKG-Background Material,2009-12-30T05:00:00Z,2009,12,,,2010-03-04T03:57:45Z,,0,0,0900006480a7336d
FDA-2009-N-0592-0003,FDA,FDA-2009-N-0592,"Reference 2 - ""World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects"" - [Informed Consent Elements]",Supporting & Related Material,BKG-Background Material,2009-12-30T05:00:00Z,2009,12,,,2010-03-04T03:59:28Z,,0,0,0900006480a733cd
FDA-2009-N-0592-0005,FDA,FDA-2009-N-0592,"Reference 4 - ‘‘National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, ‘‘The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research’’ - [Informed Consent Elements]",Supporting & Related Material,BKG-Background Material,2009-12-30T05:00:00Z,2009,12,,,2010-03-04T04:01:40Z,,0,0,0900006480a7340b
FDA-2009-N-0592-0001,FDA,FDA-2009-N-0592,Informed Consent Elements,Proposed Rule,NPR-Notice of Proposed Rule-Making,2009-12-29T05:00:00Z,2009,12,2009-12-29T05:00:00Z,2010-03-02T04:59:59Z,2011-06-11T16:28:10Z,E9-30751,0,0,0900006480a7316e